Aug 10, 2010

We also have received feedback from the FDA confirming that we can use our Phase 3 CONCERT trial to complete our registration package for mild-to-moderate Alzheimer's disease, provided that the results are robustly positive.

CONCERT is a safety and efficacy study evaluating Dimebon in Alzheimer's patients with mild to moderate Alzheimer's Disease and who are also taking Aricept (Donepezil). In other words, a phase three clinical trial and probably the last gasp effort for Medivation to gain approval for Dimebon as a treatment for Alzheimer's disease.

Long shot probably. However, as I read those words I was thinking like an investor. No I do not, nor have I ever, owned Medivation (MDVN). Full Disclosure.

You might be wondering what I was thinking. I thought to myself, if Dimebon ever gets approved it will have any enormous market at least in the first years. Why you ask?

My mother suffers from Alzheimer's disease. She was in the Medivation Dimebon clinical trial for moderate to severe Alzheimer's disease. This is later stage Alzheimer's. Pfizer (PFE) and Medivation canceled the clinical trial my mother was enrolled in -- they abandoned the trial.

I'll make my investor point first before I get into the background and explanation.

If Dimebon every gets to market I am going to be first in line to buy. Now, it won't be approved for my mother because she is in the moderate to severe stage of Alzheimer's. That won't stop us.

Take a look at Namenda (Forest Labs, FRX). A large number of the Alzheimer's patients on Namenda are in the mild to moderate stage of Alzheimer's. Never mind that Namenda is only approved by the FDA for prescription to later stage Alzheimer's patients -- moderate to severe Alzheimer's.

The above regulation is not stopping doctors from prescribing the combination of Aricept and Namenda to early stage patients -- see

I should add. Forest Labs (FRX) did apply for FDA approval for use with early stage patients -- their petition was denied. A result I can not understand. Seems the marketplace ignored the FDA -- in part.

Now Our Dimebon story and experience.

My mother was doing wonderfully well in weeks 6 through 18 of her Dimebon clinical trial. This is no bull. I wrote about this while it was happening so our story is documented here. Then, the clinical trial was canceled. Remember, I never owned MDVN, so I am not a promoter here.

My mother was actually on the combination of Dimebon and Namenda (not Aricept). This differs from CONCERT which is the combination of Dimebon and Aricept.

My mother was not the only patient that benefited from Dimebon or had a remarkable positive experiences with Dimebon. Any and all combinations.

Several of the Alzheimer's caregivers in a Dimebon clinical trial came on to this blog and wrote about their own very positive experience. Several were in the open label extension phase. Meaning they have moved beyond the 26 week clinical trial phase. Dimebon was working remarkably well for them.

In my role here as editor of the Alzheimer's Reading Room, I get to talk to neurologists around the country. Nine different neurologists that had direct contact with caregivers enrolled in the study all said the same thing: they received substantial and direct feedback that many of the patients on Dimebon were more engaged.

In Alzheimer's speak "more engaged" means "more there." It means more alive, brighter look on the patients face, actually reacting to stimuli like television and the newspaper.

Imagine you are caring for someone for years and all that time they are "not there". Then all of a sudden not only are they there, they are "more there". Try and imagine what that might feel like. Now multiple by a thousand -- you are getting close. It is like being reborn.

I know how this feels because I live in the front row of Alzheimer's disease and my mother came back for 12 weeks or so. I experienced what I am writing about here.

No, her short term memory didn't come back. Her ability to laugh, to discuss news and to play bingo all came back. Imagine this. She goes to the bingo hall and wins the coverall game. To win the coverall you have to have every single number on the bingo card. My mother marked every number all by herself, without assistance. Her friend did have to yell bingo for her. Mom is past the point where she can figure out if she has bingo.

It didn't stop there. I went to pick her up and there she was with her fifty bucks in hand, smiling like the Cheshire cat. We get home and before long my mother is yelling Bobby Bobby Bobby from her bedroom. I run up there worried about what is happening. There she stands. She went into her cash stash, figured out that half of 50 is 25, got out a 20 and a 5 and gave me half of her winnings.

The above might not sound like much unless you put it in context. The previous hundred times my mother had asked me if she had any money I said, "look in your cash stash". Care to guess what she said? Every single time, where is it? She had no idea what her cash stash was, or where it was.

Back to Medivation.

I know as an X employee of a Wall Street firm that a lot of investors have gotten killed in Medivation (MDVN). Many of them have thrown in the towel. Some are hoping for a miracle.

You are not the only one's hoping for a miracle. There are many thousands of Alzheimer's caregivers, their families, and friends that are pulling for the approval of Dimebon. Many of these caregivers, like me, cannot believe the drug failed because in our eyes it didn't fail. Yes, it failed to improve memory, but we saw something very different -- it improved behavior. We saw with our own eyes, minds and heart -- "more there".

If Dimebon ever makes it to market it won't be limited in use to early stage Alzheimer's patients -- mild to moderate Alzheimer's disease -- and/or only those patients on Aricept.

The Alzheimer's caregiving community is vast and it is well networked. The word will spread if the drug is approved and becomes available. Everyone that can afford the drug will try it.

I'll be standing there with my prescription in hand on day one. I am confident when I say -- I won't be alone.

My own personal experience with the combination of Namenda and Dimebon tells me that this combination works. It worked for my mother. I doubt she is the only one it worked for. However, I can't say how effective it might or could be across the entire population of those suffering Alzheimer's disease. I doubt my mother is unique.

I can say this, if Dimebon comes to market it will be a monster drug. Bigger than any analyst would ever dare to say upfront.

If you are an investor you might consider subscribing to this blog. If you know someone that has been touched by Alzheimer's you might consider telling them about us and suggesting they subscribe. Shoot us up to Twitter or Facebook.

Feel free to email this article to your investor friends or to put the link on message boards.

Remember to take good care of your brain. Alzheimer's is a vicious, sinister disease.

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Bob DeMarco is the editor of the Alzheimer's Reading Room and an Alzheimer's caregiver. Bob has written more than 1,750 articles with more than 80,000 links on the Internet. Bob resides in Delray Beach, FL.

The Alzheimer's Reading Room does not provide medical advice. The contents are for informational purposes only, and are not intended to substitute for professional medical advice, diagnosis or treatment. The views of the individuals that write on this website, contribute articles, or are quoted on this site are not necessarily those of the Alzheimer's Reading Room. For specific, personalized medical advice we encourage you to contact your physician.Unauthorized use and/or duplication of all materials and articles in the Alzheimer's Reading Room without the express and written permission from Bob DeMarco are strictly prohibited. Excerpts and links may be used, provided that full and clear credit is given and appropriate and specific direction to the original content is included.